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Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kiadis Pharma
ClinicalTrials.gov Identifier:
NCT01794299
First received: February 14, 2013
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor.

Condition Intervention Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Biological: ATIR Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Resource links provided by NLM:


Further study details as provided by Kiadis Pharma:

Primary Outcome Measures:
  • Transplant-related mortality (TRM) [ Time Frame: At 6 months post HSCT ]

Secondary Outcome Measures:
  • Immune reconstitution [ Time Frame: Up to 24 months post HSCT ]
  • TRM [ Time Frame: Up to 24 months post HSCT ]
  • Relapse-related mortality (RRM) [ Time Frame: Up to 24 months post HSCT ]
  • Overall survival (OS) [ Time Frame: Up to 24 months post HSCT ]
  • Progression-free survival (PFS) [ Time Frame: Up to 24 months post HSCT ]
  • Incidence of viral, fungal, and bacterial infections [ Time Frame: Up to 24 months post HSCT ]
  • Severity of viral, fungal, and bacterial infections [ Time Frame: Up to 24 months post HSCT ]
  • Incidence of acute and chronic graft versus host disease (GvHD) [ Time Frame: Up to 24 months post HSCT ]
  • Severity of acute and chronic GvHD [ Time Frame: Up to 24 months post HSCT ]

Enrollment: 31
Study Start Date: March 2013
Estimated Study Completion Date: October 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATIR Biological: ATIR
Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.

Detailed Description:
Study CR-AIR-007 is an exploratory, open-label, multicenter study. After signing informed consent, patients will receive a hematopoietic stem cell transplantation (HSCT) from a related, haploidentical donor, followed by infusion with ATIR between 28 and 32 days after the HSCT (or later if required by the patient's medical condition). Patients will receive ATIR as a single infusion at a dose of 2x10E6 viable T-cells/kg. All patients treated with ATIR will be followed up until 12 months after the HSCT. Assessments will be performed at weekly visits from the day of ATIR infusion until 8 weeks after ATIR infusion, at monthly visits from 3 until 6 months after the HSCT, every 2 months from 6 until 12 months after the HSCT, and every 6 months from 12 until 24 months after the HSCT.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any of the following hematologic malignancies: a) Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission b) Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission c) Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher Revised International Prognostic Scoring System (IPSS-R) risk group
  • Eligible for haploidentical stem cell transplantation according to the investigator

Exclusion Criteria:

  • Availability of a suitable matched related or unrelated donor following a donor search
  • In second or higher remission with the previous remission having lasted less than 6 months
  • Diffusing capacity for carbon monoxide (DLCO) < 50% predicted
  • Left ventricular ejection fraction < 50% (evaluated by echocardiogram or multiple gated acquisition [MUGA])
  • Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)(CTCAE grade 2)
  • Bilirubin > 1.5 x ULN (CTCAE grade 2)
  • Creatinine clearance < 50 mL/min (calculated or measured)
  • Positive test for human immunodeficiency virus (HIV)
  • Positive pregnancy test (women of childbearing age only)
  • Prior allogeneic stem cell transplantation using stem cells from a matched sibling donor, a matched unrelated donor, a haploidentical donor, or a cord blood donor
  • Prior autologous stem cell transplantation
  • Stay at intensive care unit for more than 2 months in the preceding 12 months
  • Estimated probability of surviving less than 3 months
  • Known allergy to any of the components of ATIR (e.g., dimethyl sulfoxide)
  • Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study

Donor inclusion criteria

  • Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype
  • Male or female, age ≥ 16 and ≤ 75 years
  • Eligible for donation according to the transplantation center

Donor exclusion criteria

  • Positive viral test for HIV-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, human T-lymphotropic virus (HTLV)-1*, HTLV-2*, or WNV* (if tested) (* at Canadian centers only)
  • Positive pregnancy test or nursing (women of childbearing age only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794299

Locations
Belgium
Algemeen Ziekenhuis Sint-Jan
Brugge, Belgium, 8000
Université Libre de Bruxelles - Institute Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Canada, Ontario
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Germany
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 ONN
Sponsors and Collaborators
Kiadis Pharma
Investigators
Study Chair: Denis Claude Roy, Prof MD Maisonneuve-Rosemont Hospital, Montreal Quebec
  More Information

Responsible Party: Kiadis Pharma
ClinicalTrials.gov Identifier: NCT01794299     History of Changes
Other Study ID Numbers: CR-AIR-007
2012-004461-41 ( EudraCT Number )
File # 9427-K0980\1-21C ( Other Identifier: Health Canada )
Study First Received: February 14, 2013
Last Updated: August 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kiadis Pharma:
Haploidentical stem cell transplantation
Graft-versus-host disease
Immune reconstitution
Alloreactive T-cells
Photodepletion
Photodynamic treatment
TH9402
Transplant-related mortality
Hematologic malignancy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 23, 2017